MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 1, SHORT NECK; CEMENTED STEM

Model Number	01.12.41SN
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 january 2021: lot 2007204: 20 items manufactured and released on 15-oct-2020.Expiration date: 2025-10-06.No anomalies found related to the problem.To date, 4 items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs manager: early infection in hybrid tha, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices additional items involved in the event, batch review performed by on 18 january 2021.These items were revised on 23-dec-2020 liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.2003330 lot 2003330: 176 items manufactured and released on 3-jul-2020.Expiration date: 2025-06-17.No anomalies found related to the problem.To date, 103 items of the same lot have been sold without any similar reported event.Ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot.188825 lot 188825: 100 items manufactured and released on 6-mar-2019.Expiration date: 2024-02-25.No anomalies found related to the problem.To date, 96 items of the same lot have been sold without any similar reported event.Additional items involved in the event, batch review performed by on 12 january 2021: ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot.1905319 lot 1905319: 110 items manufactured and released on 28-nov-2019.Expiration date: 2024-11-18.No anomalies found related to the problem.To date, 100 items of the same lot have been sold without any similar reported event.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.182609 lot 182609:110 items manufactured and released on 2-jul-2018.Expiration date: 2023-06-18.No anomalies found related to the problem.To date, 99 items of the same lot have been sold without any similar reported event.Cup: mpact 01.32.150dh acetabular shell ø50 two-holes (k1328799) lot.2003357 lot 2003357: 130 items manufactured and released on 27-jul-2020.Expiration date: 2025-07-15.No anomalies found related to the problem.To date, 84 items of the same lot have been sold without any similar reported event.Mectaplug 01.33.101 mectaplug pe size 1 lot.2003075 (item not registered in usa) lot 2003075: 410 items manufactured and released on 22-jul-2020.Expiration date: 2025-07-09.No anomalies found related to the problem.To date, 282 items of the same lot have been sold without any similar reported event.
Event or Problem Description
On (b)(6) 2020, one month after the primary surgery a washout was performed, on (b)(6)2020, the surgeon performed again a washout and revised the liner and head due to infection.Blood culture still positive for e coli.The surgeon finally revised all implants on (b)(6) 2021 via posterior approach and implanted competitor implants.

• Brand Name: STEM: QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 1, SHORT NECK
• Common Device Name: CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11185283
• Report Number: 3005180920-2021-00052
• Device Sequence Number: 13645009
• Product Code: LZO
• UDI-Device Identifier: 07630030802799
• UDI-Public: 07630030802799
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2025
• Device Model Number: 01.12.41SN
• Device Catalogue Number: 01.12.41SN
• Device Lot Number: 2007204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2020
• Initial Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 100